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. 2013 Sep 3;2013(9):CD001073. doi: 10.1002/14651858.CD001073.pub2

Lakatos 1986.

Methods A single‐centre, randomised, prospective controlled trial
Participants 204 outborn infants
Inclusion criteria: premature infants, 751 to 2000 g BW, born between 1 January 1983 and 6 March 1984
Exclusion criteria: congenital abnormalities, death before 6 h of life
Interventions Intervention group (n = 100)
BW < 1500 g: D‐penicillamine intravenously started within 12 h after birth, 300 mg/kg/day (divided in 3 doses) x 3 days, then 50 mg/kg/day (in a single dose) until 2 weeks of age
BW 1500‐2000 g: D‐penicillamine intravenously started within 12 h after birth, 300 mg/kg/day (divided in 3 doses) x 3 days; additional 50 mg/kg/day doses if they required oxygen beyond 3 days
Control group (n = 104). No placebo was used in controls
 Once ROP developed after 6 weeks of age, D‐penicillamine 50 mg/kg/day was given to infants in the control group for 3 weeks
Outcomes Death before discharge
 Any ROP in survivors
Notes Follow‐up at 1 year of age for anthropometry and neurodevelopment presented in separate study (Vekerdy‐Lakatos 1987)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Authors do not provide the exact method of random sequence generation
Allocation concealment (selection bias) Low risk Sealed envelopes
Blinding (performance bias and detection bias) 
 All outcomes High risk No blinding
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Group assignment not concealed from paediatricians, but ophthalmologists doing ROP examinations were masked to study group
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Outcomes of ROP reported on the majority of enrolled infants
Selective reporting (reporting bias) Unclear risk The study protocol was unavailable